Pre-oxygenation With High-flow Nasal Cannula in Comparison to Standard in Adults During Rapid Sequence Induction Anesthesia- a Prospective Randomized Non-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Lowest peripheral oxygen saturation from induction of anaesthesia to 1 minute after tracheal intubation
研究概览
简要总结
Pre-oxygenation with high-flow nasal cannula oxygen has been evaluated in a limited number of studies and seems to be better than traditional preoxygenation with a tight fitting mask. Oxygenation with high-flow nasal cannula in apnea demonstrates that this could be done safely for up to 25 mins with preserved saturation. Based on this, the investigators want to evaluate whether this novel concept of preoxygenation can prolong the time to desaturation in emergency anesthesia while securing a possibly difficult airway. This may reduce the number of hypoxic events during intubation. This novel concept has already been tested in clinical practice in certain cases but not during rapid sequence induction for acute surgery.
Objectives and Purpose The general purpose of this project is to compare a new preoxygenation technique based on humidified oxygen in a high-flow nasal cannula with traditional preoxygenation with a tight fitting mask during rapid sequence induction intubation with focus on gas exchange.
详细描述
Pre-oxygenation with high-flow nasal cannula with 100% oxygen has been evaluated in a limited number of studies and seems to be equal or better than traditional preoxygenation with tight fitting mask. Apneic oxygenation with high-flow nasal cannula in apnea demonstrates that this could safely be don up to 25 minutes. Based on this, we can to evaluate whether this novel concept of preoxygenation can prolong the time before desaturation in emergency anesthesia and a difficult airway situation. This could ultimately reduce the number of damage to the airway and hypoxic injuries. This novel concept is already tested in clinical practice in certain cases and we strongly believe that a scientific evaluation of this approach is needed before a broad implementation.
The patients will undergo regular pre-anesthetic evaluation and will be then be asked to participate in the study. Oral and written information will be given. A consent form will be signed.
The patients will be randomized to either traditional preoxygenation or preoxygenation with high-flow nasal cannula (HFNC) oxygen.
On arrival in the operating room standard patient monitoring will be applied (ECG, pulse oximetry, non-invasive blood pressure) and preparation for anesthesia induction will be done with the patients placed with a slightly elevated head, approximately 25º. Peripheral oxygen saturation (SpO2) will be noted when breathing room air. If an arterial line is planned this will be put in place before pre-oxygenation and a blood sample will be drawn when breathing room air Preoxygenation will hereafter take place either the traditional way or with a HFNC. The traditional preoxygenation consists of breathing 100% oxygen via a tight-fitting non-rebreathing facial mask with a fresh gas flow of ≥10 L/min of for ≥ 3 minutes. HFNC pre-oxygenation consists of application of nasal cannulae (Optiflow TM, Fisher & Paykel Healthcare, Auckland, New Zealand) in the nostrils and the patients will receive 40L/min of heated and humidified 100% oxygen for ≥ 3 minutes.
After induction of anesthesia with RSI the airways will be kept open by manual adjustment by the anesthesiologist until intubation regardless of pre-oxygenation technique. During the laryngoscopy and intubation 70L/min of humidified 100% oxygen will be administered continuously by the nasal cannula left in place if HFNC oxygen is used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, >18 years old
- •Emergency intubation where RSI is indicated
- •Capable of understanding the study information and signing the written consent.
- •Need for non-invasive ventilation
排除标准
- 未提供
研究组 & 干预措施
Pre oxygenation with 100% oxygen in high-flow nasal cannula
Pre Oxygenation will be done using high-flow nasal canula
干预措施: High-flow nasal cannula (Procedure)
Pre oxygenation with 100% oxygen via tight fitting mask
Pre Oxygenation will be done using a tight mask
结局指标
主要结局
Lowest peripheral oxygen saturation from induction of anaesthesia to 1 minute after tracheal intubation
时间窗: One minute after tracheal intubation
Peripheral oxygen saturation will be measured. The lowest value from start of anesthesia until up to 1 minute after tracheal intubation is the primary outcome measure.
次要结局
- Change in level of oxygen saturation during high flow nasal cannula oxygenation compared with traditional pre-oxygenation from time to first anesthetic drug given to 1 minute after intubation.(One minute after tracheal intubation)
- Number of patients with desaturation below 93 % with high flow nasal cannula oxygenation compared with traditional pre-oxygenation?(One minute after tracheal intubation)
- Degree of discomfort with pre oxygenation for the patient(The assessment will be done at the postoperative unit)
- Level of end tidal carbon dioxide in the first breath after intubation with high flow nasal cannula oxygenation compared with traditional pre-oxygenation?(First breath after endotracheal intubation)
研究者
Malin Jonsson Fagerlund
Associate Professor, senior Consultant
Karolinska University Hospital